CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics

November 7, 2011 updated by: Sorin Group USA, Inc.

A Randomized Study to Compare Sizing, Implant Techniques, & Hemodynamic Performance Between the CarboMedics Supra-annular Top Hat Valve and the St. Jude Medical Regent Valve in the Aortic Position.

The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Wellmont Holston Valley Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are indicated for implant with a mechanical valve prosthesis in the aortic position according to the current practice for valve selection at the center.

Exclusion Criteria:

  • Patients < 18 years of age
  • Emergency surgery
  • Pre-existing valve prosthesis
  • Aortic root replacement
  • Active endocarditis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
CarboMedics Supra-annular Top Hat Valve
Device: Top Hat
Implant of CarboMedics Top Hat mechanical valve.
Active Comparator: 2
St. Jude Medical Regent Valve
Device: Regent
Implant of the St. Jude Medical Regent mechanical valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective Orifice Area (EOA)
Time Frame: 6 month evaluation
Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.
6 month evaluation
Aortic Mean Gradient
Time Frame: 6 months
Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorin Group USA, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (Estimate)

February 20, 2008

Study Record Updates

Last Update Posted (Estimate)

November 16, 2011

Last Update Submitted That Met QC Criteria

November 7, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVSS-1H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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